FDA 510(k) Application Details - K072211

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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510(K) Number K072211
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE, CA 94086-5206 US
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Contact MICHAEL H YRAMATEGUI
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 08/09/2007
Decision Date 02/28/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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